Proheal Pharmaceuticals, a Suzhou-based developer of drugs for ophthalmology and autoimmune diseases, announced the first subject dosing in a clinical study for its in-house developed anti-IGF1R antibody PHP1003 in thyroid-associated ophthalmopathy (TAO). This marks a significant milestone in the development of novel treatments for this condition.
Study Design and Drug Profile
The Phase I study is a randomized, double-blind, placebo-controlled, single, and multiple dosage escalation trial designed to assess the safety, tolerability, pharmacokinetics, and immunogenicity of PHP1003 in healthy subjects in China. PHP1003 obtained tacit clinical trial approval in June 2022 and is the first of its kind to enter the clinic in the country. The drug is also being developed in a subcutaneous injection form.
Thyroid-Associated Ophthalmopathy and Market Context
Thyroid-associated ophthalmopathy (TAO) is an autoimmune disease caused by autoantigens expressed by thyroid epithelial cells, periorbital adipocytes, and fibroblasts, with a prevalence of 0.1% to 0.3%. Horizon Therapeutics’ Tepezza (teprotumumab) became the first monoclonal antibody (mAb) and IGF-1R-targeted drug to treat TAO when it obtained market approval in the US in January 2020. Tepezza generated USD 1.6 billion in sales in 2021 and is expected to reach a peak value of USD 3.5 billion.
Future Outlook
With the initiation of the clinical study, Proheal Pharmaceuticals is poised to advance PHP1003 as a potential new treatment option for patients with thyroid-associated ophthalmopathy. The company aims to leverage the drug’s unique mechanism of action to address the significant unmet need in this therapeutic area.-Fineline Info & Tech
